MAUDE Adverse Event Report: B. BRAUN MEDICAL INC APEX¿; COMPOUNDER

Model Number 601224

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As per user facility: customer reported they had added the new smoflipid to their scdm database earlier in the day but the compounder was not pumping the correct amount for the patient order.The compounder was pumping water instead of the smoflipid solution.No patient involvement.

Event Description

As per user facility: customer reported they had added the new smoflipid to their scdm database earlier in the day but the compounder was not pumping the correct amount for the patient order.The compounder was pumping water instead of the smoflipid solution.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).No logs or files were returned for evaluation.To determine a potential root cause a copy of the database or the patient file is required and therefore the event cannot be confirmed.This is likely an issue with the customer's setup of the database or how the patient file (.Pat) was generated.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX¿
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 8955177
• MDR Text Key: 158637397
• Report Number: 1641965-2019-00014
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046964801068
• UDI-Public: (01)04046964801068
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 601224
• Device Catalogue Number: 601224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1